Future of Cell Therapy in the Regenerative Medicine Market

Combination Therapies and Advanced Manufacturing Techniques are the New Criteria Shaping the $4 Billion Market

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Research Overview
This Frost & Sullivan research service analyses the current trends, forecasts and the external factors influencing the global cell therapy market. It also studies top participants in the market, disruptive pipeline products, and the opportunities in combination therapy. In addition, it provides a detailed commercialization analysis of research and development (R&D), manufacturing, and funding considerations.

In this research, Frost & Sullivan's expert analysts thoroughly examine the following market segments:

  • Cell-based immunotherapy
  • Stem cell therapy
  • Cell-gene therapy
  • Stem cell-gene therapy

They also analyze the following geographic segments in detail:

  • North America (Canada, the United States of America)
  • Europe (Germany, United Kingdom, Benelux, Spain, France, Scandinavia, Italy)
  • Asia-Pacific (Japan, Association of South East Asian Nations (ASEAN), China, India)
  • Rest of the world (Brazil, Africa, Russia)

Market Overview

Late Stage Hybrid Cell Therapy to Disrupt the Overall Cell Therapy Market

Heavy investments in the development and commercialization of cell therapy products have made North America the forerunner with 50 percent share in the global cell therapy market. However, the Asia-Pacific market is growing at a faster rate, on the strength of the intensified R&D activity in Japan and South Korea. Meanwhile, the pressure to reduce the cost of care for aging population has driven the governments in some countries including, Japan, Canada, and the United States to create programs to facilitate the rapid commercialization of therapy products. Accordingly, the United States and Japan have fast tracked R&D in treatments that employ highly curative stem cell, cell-gene, and immunotherapy. Many governments in North America and the Asia-Pacific are drafting policies to encourage the establishment of centers of excellence, manufacturing infrastructure and research networks to ensure profitable commercialization of products.

Despite these external drivers, the market is hindered to some extent by the lack of viable manufacturing infrastructure that supports the mass production of quality cell therapy products. Therefore, large-scale manufacturing units for autologous cell therapy and combination therapy products are necessary to meet the market demand. Manufacturers across segments could emulate the sustainable manufacturing models currently used by the market leaders to develop strategic facilities and deploy automated machinery to increase the output.

Nevertheless, the cell therapy market is growing exponentially with technical advancements in various areas. Commercializing late stage hybrid therapy will disrupt the mainstream cellular therapy market. Allogeneic therapy is expected to enjoy significant uptake as the overall market perceptibly shifts from autologous to allogeneic treatments. Market participants are also striving to find treatments for chronic diseases, with close to 50 percent of their pipeline therapy focused on oncology. Evidently, innovative treatments and sustainable manufacturing models are critical for success in this market.

Table of Contents

1. Scope and Segmentation
Main Focus Regions
Overall Regenerative Market
Base Year
Study Period
2. Executive Summary
Key Takeaways— how is this Market Important to You?
Established Cell Therapy Companies
Small- to Medium-sized Companies
Pharmaceutical Companies
Support Industry Expansion
Manufacturing Facilities
Executive Summary—Market Snapshot
Restraints
Lack of early-stage funding curtails innovative products from reaching the market.
Inherent variability in cells and cultures make scaling-up a challenge.
Undefined federal regulations for cell production and testing.
High patient treatment cost.
Lack of clear healthcare reimbursement pathways.
Drivers
Growing aging populations with higher of disease prevalence calls for alternative treatments.
High cost of socialized medicine in many countries.
Increasing clinical evidence of efficacy with “curative” potential, especially with cell-gene therapies.
Cell therapy is increasingly being adopted by physicians.
Both public and private funding is becoming more available for research and development (R&D), early-, and late-stage clinical trials.
Pharmaceutical companies are becoming “interested”.
Key 2016 Predictions—Cell Therapy Market
Big Market Themes for Cell Therapy
MSCs Dominate the Market
Opportunities Within the Ecosystem
Market Moving to Focus on Key Need Areas
Funding Splurge
Companies Ramping up R&D
Increasing Collaborative Activities
Regional Regulations are Changing to Accommodate Cell Therapy
Disruptive Therapies
A Vibrant Ecosystem - Total Cell Therapy Market: Ecosystem, Global, 2015
Paradigm Shift to Chronic Disease Therapies
Regional Highlights and Developments
Game-changing Companies
Private Investors Pour in Significant Funds
3. Disruptive Pipeline Analysis
Key Methodology
Next Wave of Cell Therapy
Potential Launch Dates
Overall Breakdown of Cell Therapy Market
Competitive Landscape of Marketed Products
Cell Therapy—Competitive Landscape of Products in Development
Potential Game-changing Therapies
4. Product Dashboard of Leading Commercial Cell Therapy Products
Product Dashboard
Apligraf (Organogenesis)
GINTUIT (Organogenesis)
Grafix (Osiris Therapeutics)
Dermagraft (Shire)
Osteocel Plus (NuVasive)
ReCell Spray-on Skin (Avita Medical)
Trinity Evolution (Orthofix)
BioDfactor (BioD, LLC)
BioDfence (BioD, LLC)
5. Key Companies and Products to Watch by Indication
Competitive Overview of Established Companies
Avita
Mesoblast
Pharmicell
Shire
Others
Cell Therapy—Cardiovascular
C-Cure (Celyad)
Heartcel (Cell Therapy LTD)
MyoCell (BioHeart)
Cell Therapy—Immunology
Prochymal (Mesoblast)
Cx601 (TiGenix)
MPC-100-IV (Remestemcel-L; Mesoblast)
Cell Therapy—Oncology
NiCord (Gamida Cell)
StemEx (Gamida Cell)
ImmuniCell (TC BioPharm)
Cell Therapy—Musculoskeletal
NeoCart (Histogenics)
NOVOCART 3D (Aesculap/B. Braun)
Cell Therapy—Dermatology
ALLO-ASC-DFU (Anterogen)
Cell Therapy—Neurology
MPC-06-ID (Mesoblast)
6. Opportunities in Combination Therapies
Cell-gene Therapies and How They Work
Key Product Example to Watch For
CTL019 (Novartis)
JCAR015 (Juno Therapeutics)
KTE-C19 (Kite Pharmaceutical)
Disruptive Technologies and Advances in this Field
Lentivirus
CRISPR
7. Commercialization Analysis
Opportunities in this Market
Overall Environmental Impact Factors
8. Commercialization Analysis—R&D Considerations
Ongoing Stem Cell Clinical Trials by Indication
Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials
Commercial Considerations for Selections of Cell Type
9. Commercialization Analysis—Regulatory Considerations (Despite popular belief, Frost & Sullivan’s pipeline data indicates an equal numbers of allogeneic and autologous clinical trials.)
Cell Therapy Regulatory Process
A Snapshot of Regulatory Policies for Stem Cell Therapy
Canada’s Unique Infrastructure—Center of Excellence
Japan’s Unique Regulatory Infrastructure
10. Commercializing Analysis—Manufacturing Considerations (The market is shifting away from autologous therapies towards allogeneic cell therapies.)
Autologous versus Allogeneic Cell Products
Manufacturing Models that Work
TiGenix
Mesoblast
Manufacturing Models that Failed
Dendreon Therapeutics
11. Commercialization Analysis—Funding Considerations (Pushing Products Past the “Valley of Death”)
Funding Key Points – Trends
Venture Investments Rapidly Growing
Hope for Early Stage Products
Stagnation of New Start-ups
Short Venture Financing Life Cycle
Difficult to Raise Capital for New Deals
Cell Therapy Deals from 2010 to 2015
Funding Environment—Where are the Funds Coming From?
Merger, Acquisition, and Partnership Assessment
Healios and Athersys (ATHX)
NeoStem and Invetech
Takeda and NsGene
SQZ Biotech and Roche
CTM CRC, CCRM, and Cell Therapy Catapult
Stem Cell Therapeutics Corp./ Trillium Therapeutics Inc.
BioTime Inc./Geron Corporation
Mesoblast/Osiris Therapeutics
Living Cell Technologies Limited (LCT)/ Otsuka Pharmaceutical Factory Inc. (OPF)
Smith & Nephew plc/ Healthpoint Biotherapeutics
AxoGen Inc./PDL BioPharma Inc.
Kensey Nash/Royal DSM
Shire Plc/Pervasis Therapeutics
Cytomedix Inc./ Aldagen
Cell Therapy Market—Funding Scenario
Cytori Therapeutics Inc.
bluebird bio
Histogenics Corporation
Fibrocell Science Inc.
Others
12. Conclusion and Take Home Points
Key 2016 Predictions—Cell Therapy Market
Key Conclusions and Future Outlook
Growth Opportunities in Top Segments
Cell Therapy Overall
Stem Cell
Immunotherapy
Cell-Gene
Pitfalls to Avoid
Network & Logistics
Efficient Technology
Funding Concerns
Regulatory Processes
Business Model Inadequacies
13. Legal Disclaimer
14. Appendix—Cell Therapy Major Clinical Trial Milestones
Cell Therapy Market—Major Ongoing/Recently Completed Clinical Trials


List of Figures & Charts

1. Total Cell Therapy Market: Key Market Metrics, Global, 2015
2. Total Cell Therapy Market: Regional Market Share, Global, 2015
3. Total Cell Therapy Market: Ecosystem, Global, 2015
4. Total Cell Therapy Market: Regional Highlights, Global, 2015
5. Cell Therapy Market: Examples of Key Companies, Global, 2015
6. Cell Therapy Market: Key Methodology, Global, 2015
7. Cell Therapy Market: Potential Market Launches, Global, 2015–2030
8. Cell Therapy Market: Overall Pipeline Breakdown, Global, 2015
9. Cell Therapy Market: Overall Breakdown by Promising Indications, Global, 2015
10. Cell Therapy Market: Potential Market Launches, Global, 2016–2019
11. Cell Therapy Market: Potential Market Launches, Global, 2016–2019
12. Cell Therapy Market: Apligraf Product Dashboard, Global, 2015
13. Cell Therapy Market: GINTUIT Product Dashboard, Global, 2015
14. Cell Therapy Market: Grafix Product Dashboard, Global, 2015
15. Cell Therapy Market: Dermagraft Product Dashboard, Global, 2015
16. Cell Therapy Market: Osteocel Plus Product Dashboard, Global, 2015
17. Cell Therapy Market: ReCell Spray-on Skin Product Dashboard, Global, 2015
18. Cell Therapy Market: Trinity Evolution Product Dashboard, Global, 2015
19. Cell Therapy Market: BioDfactor Product Dashboard, Global, 2015
20. Cell Therapy Market: BioDfence Product Dashboard, Global, 2015
21. Cell Therapy Market: Percent Breakdown of Commercially Available Products by Therapeutic Area, Global, 2015
22. Cardiovascular Segment: Key Product Launch* Timeline, Cell Therapy, Global, 2015–2020
23. Key Trends in Cardiovascular Cell Therapy, Global, 2015
24. Cell Therapy Market: C-Cure Product Dashboard, Global, 2015
25. Cell Therapy Market: Heartcel Product Dashboard, Global, 2015
26. Cell Therapy Market: MyoCell Product Dashboard, Global, 2015
27. Immunology Segment: Key Product Launch Timeline, Cell Therapy, Global, 2015–2020
28. Key Trends in Immunology Cell Therapy, Global, 2015
29. Cell Therapy Market: Prochymal, Product Dashboard, Global, 2015
30. Cell Therapy Market: Cx601, Product Dashboard, Global, 2015
31. Cell Therapy Market: MPC-100-IV Product Dashboard, Global, 2015
32. Oncology Segment: Key Product Launch Timeline, Cell Therapy, Global, 2015–2020
33. Key Trends in Oncology Cell Therapy, Global, 2015
34. Cell Therapy Market: NiCord, Product Dashboard, Global, 2015
35. Cell Therapy Market: StemEx Product Dashboard, Global, 2015
36. Cell Therapy Market: ImmuniCell Product Dashboard, Global, 2015
37. Musculoskeletal Segment: Key Product Launch Timeline, Cell Therapy, Global, 2015–2020
38. Key Trends in Musculoskeletal Cell Therapy, Global, 2015
39. Cell Therapy Market: NeoCart Product Dashboard, Global, 2015
40. Cell Therapy Market: NOVOCART 3D Product Dashboard, Global, 2015
41. Dermatology Segment: Key Product Launch Timeline, Cell Therapy, Global, 2015–2020
42. Key Trends in Dermatology Cell Therapy, Global, 2015
43. Cell Therapy Market: ALLO-ASC-DFU, Product Dashboard, Global, 2015
44. Neurology Segment: Key Product Launch Timeline, Cell Therapy, Global, 2015–2020
45. Key Trends in Neurological Cell Therapy, Global, 2015
46. Cell Therapy Market: MPC-06-ID Product Dashboard, Global, 2015
47. Cell Therapy Market: CTL019, Product Dashboard, Global, 2015
48. Cell Therapy Market: JCAR015 Product Dashboard, Global, 2015
49. Cell Therapy Segment: KTE-C19 Product Dashboard, Global, 2015
50. Cell Therapy Market: Game-changing Strategies, Global, 2015
51. Cell Therapy Market: Environmental Impact Factors, Global, 2015
52. Cell Types to Consider: Cord/Placental Blood
53. Cell Types to Consider: Bone Marrow
54. Cell Types to Consider: Peripheral Blood
55. Cell Types to Consider: Adipose Tissue
56. Cell Therapy Market: Clinical Trial Process, Global
57. Map: Snapshot of Regulatory Policies for Stem Cell Therapy
58. Cell Therapy Market: Regions with Best Practices, Canada, 2015
59. Cell Therapy Market: Japanese Regulatory Process, Japan, 2015
60. Cell Therapy Market: Manufacturing for ChondroCelect (Autologous Product), Europe, 2015
61. Cell Therapy Market: Manufacturing for Prochymal (Allogeneic Product), Europe and Canada, 2015
62. Cell Therapy Market: Manufacturing for Provenge (Immunotherapy), US, 2015
63. Cell Therapy Market: Key Trends in the Funding Environment, Global, 2015
64. Cell Therapy Market: Market Outlook, Global, 2012–2016
65. Cell Therapy Market: Funding Scenario, Global, 2012–2015
66. Cell Therapy Market: Key Predictions, Global, 2016
67. Cell Therapy Market: Key Conclusions and Future Outlook, Global, 2015–2020
68. Cell Therapy Market: Growth Opportunities, Global, 2016–2020
69. Cell Therapy Market: Ongoing/Recently Completed Clinical Trials Timelines and Design, Global, 2010–2016


1. Total Cell Therapy Market: Scenario Analysis, Global, 2015–2020
2. Cell Therapy Market: Percent Breakdown by Marketed Products, Global, 2015
3. Cell Therapy Market: Percent Breakdown by Pipeline Products, Global, 2015
4. Cell Therapy Market: Funding Environment, Global, 2014–2015
5. Cell Therapy Market: Outstanding Marketed Products by Therapeutic Area, Global, 2015
6. Cell Therapy Market: Products in Development by Therapeutic Area, Global, 2015
7. Cell Therapy Market: Products in Development by Therapeutic Area, Global, 2015
8. Cell Therapy Market: Marketed Products, Global, 2015 (Cardiovascular)
9. Cell Therapy Market: Marketed Products, Global, 2015 (Immunology)
10. Cell Therapy Market: Marketed Products, Global, 2015 (Oncology)
11. Cell Therapy Market: Marketed Products, Global, 2015 (Musculoskeletal)
12. Cell Therapy Market: Marketed Products, Global, 2015 (Dermatology)
13. Cell Therapy Market: Ongoing Stem Cell Studies by Indication, Global, 2015
14. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Neurology - Type of Cell Source
15. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Neurology - Cell Type
16. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Oncology - Type of Cell Source
17. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Oncology - Cell Type
18. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Autoimmune - Type of Cell Source
19. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Autoimmune - Cell Type
20. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Dermatology - Type of Cell Source
21. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Dermatology - Cell Type
22. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Cardiovascular - Type of Cell Source
23. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Cardiovascular - Cell Type
24. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Musculoskeletal - Type of Cell Source
25. Stem Cell Sources and Stem Cells Used in Pipeline Clinical Trials: Musculoskeletal - Cell Type
26. Cell Therapy Market: Total vs. Ongoing Autologous and Allogeneic Clinical Trials, Global, 2015
27. Cell Therapy Market: Number of Deals, Global, 2010–2015
28. Cell Therapy Market: Overall Deals by Indication, Global, 2015
29. Cell Therapy Market: Funding Environment, Global, 2014–2015



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